U.S. officials are warning that some counterfeit versions of Glaxo's over-the-counter diet pill Alli contain high levels of sibutramine, and are dangerous to consumers.

"The amount of sibutramine in the counterfeit Alli poses a serious health risk to some individuals," Dr. Janet Woodcock, head of the FDA's drug unit, told reporters on a conference call. "A person taking the counterfeit Alli as directed would be exposed to twice the maximum prescription dose of sibutramine every day," she said. The FDA warned earlier this year that sibutramine should not be used by people with a history of cardiovascular disease because it can raise the risk of heart attacks and strokes. The agency urged all consumers taking Alli to check they had bought legitimate versions and discard any fake products immediately.

The fake versions have some differences on the packaging, including a missing lot code on the outer cardboard packaging. Alli is the over-the-counter name for the drug, Orlistat, and is also known as tetrahydrolipstatin, and was designed to treat obesity. Its primary function is preventing the absorption of fats from the human diet, thereby reducing caloric intake. It is intended for use in conjunction with a physician-supervised reduced-calorie diet. The effectiveness of Orlistat in promoting weight loss is definite, though modest.

Pooled data from clinical trials suggests that people given Orlistat in addition to lifestyle modifications, such as diet and exercise, lose about 2-3 kilograms (4.4-6.6 pounds) more than those not taking the drug over the course of a year. Orlistat also modestly reduces blood pressure, and appears to prevent the onset of type 2 diabetes, whether due to weight loss itself or to other effects; in a large randomized controlled trial, Orlistat was found to reduce the incidence of diabetes by nearly 40 percent in obese people.

The counterfeit products were sold on the Internet, including through online auction sites, FDA officials said. There is no evidence of counterfeit versions in stores, they said. The fake products were sold as 60-milligram, 120-count refill packages only, Glaxo said. The company said it was working with the FDA to have the counterfeits removed from online auction sites.

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